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Table 2 CAR-T cell clinical trials in patients with various types of sarcomas

From: Is immunotherapy in the future of therapeutic management of sarcomas?

NCI Trial Number

Drug used

Study design

Type of sarcoma

Detailed description

Phase

Status

NCT03356782

Sarcoma-specific CAR-T cells + immune checkpoint antibodies

1 infusion, for 1 × 10^6 ~ 1 × 10^7 cells/kg via IV

Osteoid sarcoma, ES

Peripheral blood mononuclear cells (PBMCs) of patients who have CD133, GD2, Muc1, CD117 or other marker positive sarcoma will be obtained through apheresis, and T cells will be activated and modified to sarcoma-specific CAR-T cells

I/II

Recruiting

NCT04433221

Multiple sarcoma-specific CAR-T cells + sarcoma vaccines

1 infusion, CART 1 × 10^6 ~ 1 × 10^7 cells/kg via IV and vaccines 1–5 × 10^6 irradiated cells via subcutaneous injection

Osteoid sarcoma, ES

Patients eligible must have confirmed surface antigens including GD2, PSMA, Her2, CD276. This study combines multiple CAR T cells with low dose chemotherapy, such as doxorubicin to modulate surface PD-L1 level and enhance immunotherapy effect

I/II

Recruiting

NCT00902044

Autologous HER2-specific T cells + Fludarabine + Cyclophosphamide

1 infusion 1 × 10^8/m^2 autologous T cells after lymphodepleting chemotherapy

Sarcoma

Each patient had received one dose of autologous HER2-CD28 T cells. This trial used a combination of chemotherapy and HER2-specific CAR T cells.The patient with SD or a reduction in the size of the tumor,they can receive additional doses of HER2-specific T cells

I

Active, not recruiting (preliminary results available)

NCT03635632

C7R-GD2.CART cells + Cyclophosphamide + Fludarabine

Patients is assigned a dose of GD2-C7R T cells. They are treated before with cyclophosphamide and fludarabine

Neuroblastoma, osteosarcoma, ES, Rhabdomyosarcoma relapsed

uveal melanoma

Phyllodes breast tumor

These patients are injected with a GD2.C7R T cells, the retroviral vector used contains a gene that can recognize and kill cancer cells (GD2.CAR) and the new gene called C7R that will help these cells survive longer

I

Recruiting

NCT03618381

EGFR806 CAR T cell (second generation)

2 arms of the study: on Arm A, participants receive EGFR 806CAR(2G) -EGFRt, on Arm B EGFR806CAR(2G)-EGFRt and CD19CAR(2G)-T2A-HER2tG

Soft Tissue Sarcoma (ES, synovial sarcoma), osteosarcoma

Subjects receive a single dose of T cells comprised of two different subtypes of T cells (CD4 and CD8 T cells), that have been genetically modified to express the EGFR 806CAR(2G) -EGFRt—second generation. On ARM B patients receive CAR T cells directed at EGFR and CD19, a marker on the surface of B lymphocytes, that presents cells to T cells

I

recruiting

NCT02107963

Anti-GD2-CAR engineered T cells + Cyclophosphamide + AP1903

It was injected an escalating dose of autologous anti-GD2-CAR (1 × 105/106/107 transduced T cells/kg) following cyclophosphamide-based lymphodepletion

Sarcoma Osteosarcoma Neuroblastoma Melanoma

A 3rd generation anti-GD2-CAR, combined with a suicide switch caspase dimerization domain (ICD9), that induces CAR-T apoptosis in the case of several toxicity, was administred to different doses.The trial involved the use of AP1903, a dimerizing agent, administered to mediate clearance of the genetically engineered cells a in case of an unacceptable toxicity related to anti- GD2-CAR

I

Completed (results not available yet)